MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Low Blood Pressure/ Hypotension (1914); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter. Product id: 85 96sc, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient with an implantable pump for non-malignant pain. Per the session report from 2020-feb-06, the pump administered the following medications as of (b)(6) 2019: fentanyl (concentration: 2000 mcg, dose rate: 900. 09156 mcg/day), bupivacaine (concentration: 20 mg, dose rate: 9. 00092 mg/day), and morphine (concentration: 5. 8 mg, dose rate: 2. 61027 mg/day). It was reported that the patient indicated that over the past 6 weeks, a gradual increase in pain had occurred. The date (b)(6) 2020 is considered an approximate date of event (specific month and year known only). It was further noted that the patient had been in and out of the hospital due to diarrhea, hypotension and abdominal pain. The patient didn¿t feel boluses and possible withdrawals was further noted. The programming date from the most recent refill prior to event occurred on (b)(6) 2020. The clinical diagnosis was increase in pain. The date of test was (b)(6) 2020. A catheter access port (cap) contrast study on (b)(6) 2020 revealed normal catheter function. Actions taken to resolve the issue included reprogramming and an increase in fentanyl occurred on (b)(6) 2020. The event resulted in-patient hospitalization. Regarding etiology, it was indicated that the relationship of the event to the device or therapy was possibly related and it was indicated that there was no change in drug. The event was noted as not having been related to the implant procedure. The event was ongoing. No further patient complications have been reported as a result of this event.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10026715
• MDR Text Key: 190337419
• Report Number: 3004209178-2020-08126
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/05/2020 Patient Sequence Number: 1